Ariadna Regulatory provides
the thread that
guides medical device manufacturers
out of the labyrinth of
regulatory requirements.

Reach out

For Medical Device Manufacturers

In Greek mythology, Ariadna (or Ariadne) provided the thread that guided Theseus out of the Minotaur’s labyrinth.

For medical device manufacturers, established and start-ups alike, regulatory requirements may seem like a maze where great ideas get lost. The consequence? Devices are delayed in reaching the patients whose lives they could improve and the healthcare professionals whose work they facilitate.
The path forward? Tailor-made plans, protocols and reports for clinical studies and clinical evaluations in both the pre- and post-market phases light the way to device continued compliance. Well-crafted conference materials and manuscripts for peer-reviewed articles showcase data and device performance to relevant audiences.

Ariadna Regulatory provides the thread that guides medical device manufacturers out of the labyrinth of regulatory requirements.

The Services

Pre-market. Getting ready for certification

  • Clinical Investigation Plans
  • Clinical Investigation Reports
  • Usability Study Plans & Reports
  • Systematic Literature Reviews
  • Inputs to Risk Management
  • Templates for various documents

MDR Certification Support

  • Clinical Development Plans
  • Clinical Evaluation Plans
  • Clinical Evaluation Reports
  • Post-Market Clinical
    Follow-up Plans
  • Gap analysis of Technical
    Documentation

Post-Market. Ongoing Compliance

  • Plans and Reports for PMCF studies
  • Periodic updates of Clinical Evaluations
  • Updated literature reviews & vigilance reports

Science Communication

  • Manuscripts for peer-reviewed journals
  • Abstracts for conferences
  • Posters and slide decks for presentations
  • Blog posts

Client Feedback

“We have been very happy with the collaboration. Would warmly recommend to other medical device start-ups looking for a competent and dependable regulatory partner.”

“Brings a huge degree of professionalism to the task and produces meticulous work.”

”Medical writers with Teodora’s extensive clinical and regulatory knowledge base and flexible approach are difficult to find.”

”Trumps other regulatory consultants by making an effort to be available, always doing an excellent job. For a company working to very tight timelines and running at a fast-pressure pace, this has meant a lot.”

”It is a pleasure to have her by our side and fight in our corner and I totally recommend her to organisations of all sizes.”